Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
20
Countries
1
Sites
2
Refractory metastatic Her2 positive breast cancer
Key facts
- Sponsor
- Vall D Hebron Institute Of Oncology
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 May 2022 → 30 Apr 2025
- Decision date (initial)
- 2024-10-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516692-32-00
- EudraCT number
- 2020-004543-84
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Refractory metastatic Her2 positive breast cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vall D Hebron Institute Of Oncology
- Sponsor organisation
- Vall D Hebron Institute Of Oncology
- Address
- Calle Natzaret 115
- City
- Barcelona
- Postcode
- 08035
- Country
- Spain
Scientific contact point
- Organisation
- Vall D Hebron Institute Of Oncology
- Contact name
- Phase I Director
Public contact point
- Organisation
- Vall D Hebron Institute Of Oncology
- Contact name
- CRO Head
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 20 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2022-05-26 | 2022-09-28 | 2024-11-07 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-18 | Spain | Acceptable 2024-10-21
|
2024-10-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-17 | Spain | Acceptable | 2025-02-19 |